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Arjohuntleigh AB

Sweden·SE-MF-000000696

Last updated September 17, 2026

Information

Country: Sweden
Address: Hans Michelsensgatan 10, Malmö, Sweden
Website: www.arjo.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +46 10 335 4500
PRRC Contact: Maria Fagerberg
EUDAMED SRN: SE-MF-000000696
FDA FEI Number: 3002806395
DUNS Number: 355804758

Catalogue (2190)

Page 12 of 44

Device	Model / Reference	Registries	Class	Status
Maxi Move	KMCSXN-C-18	EUDAMED	Class I	Active
Smartsigns	SC1200 5NIP	EUDAMED	Class IIb	Active
Maxi Move	KMCSAE-C-18	EUDAMED	Class I	Active
Enterprise 5000x	E5X3PL103BCBOA	EUDAMED	Class I	Active
Sara Plus standing sling – extra postural support	KKA5370-L	EUDAMEDFDA UDI	Class I	Active
Sonicaid	TEAM3I NMB	EUDAMED	Class IIb	Active
Sling - Clip bathing sling – unpadded legs	MAA4060M-L	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3DR117AEDAA	EUDAMED	Class I	Active
Maxi Twin	KTBB4BSU2WW	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X32J003DBABA	EUDAMED	Class I	Active
Maxi Sky 440	LE00000-PT	EUDAMED	Class I	Active
Arjo	700-19522	EUDAMED	Class I	Active
Enterprise 5000x	E5X1HQ113BBBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1CA101AAACA	EUDAMED	Class I	Active
Maxi Sky 2 Plus	MS000-10-17	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DD102ABAAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BC101CAABA	EUDAMED	Class I	Active
Pentaflex	PS000/000	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X21AR111BFADA	EUDAMED	Class I	Active
Evenda	EM92AXE5FSJAAFA	EUDAMED	Class I	Active
Evenda	EM22BBE3CMBAAVA	EUDAMED	Class I	Active
Vhenus 2	VHCB000/000	EUDAMED	Class I	Active
Arjo	ENT-ACC67	EUDAMED	Class I	Active
Maxi Move	KMCLAN-05	EUDAMED	Class I	Active
Maxi Sky 2	MS100-01-07	EUDAMED	Class I	Active
Sara Flex	HEB0000-40	EUDAMED	Class I	Active
Enterprise 9000x	9X21AL101BFABA	EUDAMED	Class I	Active
Maxi Sky 2	MS125-V1-08	EUDAMED	Class I	Active
Maxi Move	KMCSXE-D-18	EUDAMED	Class I	Active
Maxi Move 5	KMEHL0-0	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633028SL	EUDAMED	Class I	Active
Sling - Clip bathing in situ sling – unpadded legs	MAA2070M-XL	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCSXN-D-05	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DD102ACAAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AC000ABBOA	EUDAMED	Class I	Active
Maxi Move	KMCSAE-15	EUDAMED	Class I	Active
Arjo	ENT-ACC58	EUDAMED	Class I	Active
Maxi Move	KMCEXN-D-17	EUDAMED	Class I	Active
Maxi Move	KMCSAN-D-18	EUDAMED	Class I	Active
Sling - Amputee loop hammock	MLA7000-L	EUDAMEDFDA UDI	Class I	Active
Citadel	CXX21C4X4ALMB0	EUDAMED	Class I	Active
Hydroven	5101A51	EUDAMEDFDA UDI	Class IIa	Active
Pentaflex	250PMX000/000	EUDAMEDFDA UDI	Class I	Active
Sling - Amputee clip in situ	MAA2050M0M	EUDAMED	Class I	Active
Sling - Amputee clip	MAA2090M-LL	EUDAMEDFDA UDI	Class I	Active
Sling - Loop repositioning sling	MAA6000A	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X21DQ101FDBOA	EUDAMED	Class I	Active
Auralis	636002	EUDAMED	Class IIa	Active
Enterprise 9000x	9X22CQ111DCCSA	EUDAMED	Class I	Active
Maxi Sky 2	MS110-02-07	EUDAMED	Class I	Active

Related Companies

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 11, 2013	Z-0926-2014	—	terminated	The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
Aug 18, 2009	Z-2230-2009	—	terminated	A Scoop Stretcher is made up of two frames that are held together with two locking devices, one on each end. Each locking device contains a safety latch. The safety latch could unintentionally release when the side frames are pulled for positioning.
Jun 11, 2009	Z-1946-2009	—	terminated	Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.
Apr 27, 2009	Z-1945-2009	—	terminated	The roll pin on certain configurations of the Maxilift hanger bar could break due to a combination of severe corrosion and fatigue. Breakage of the roll pin would lead to the detachment of the hanger bar from the jib of the lifter.
Feb 26, 2009	Z-1637-2009	—	terminated	If the sling clips are not applied or are applied incorrectly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver.
Feb 26, 2009	Z-1636-2009	—	terminated	If the sling clips are not applied or are applied incorrectly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Arjohuntleigh, Inc. US